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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2 INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AUTOCAT 2 INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0400
Device Problem Device Alarm System (1012)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 04/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This field service report was received late in the teleflex complaint management department from teleflex medical trading - (b)(4).
 
Event Description
It was reported per field service report: symptom - the screen turned white and the pump alarmed. The doctor changed the pump immediately as the pump stood idle. Findings / action taken: replaced the cpu (central processing unit) board. Software level: 2. 24.
 
Manufacturer Narrative
(b)(4). Evaluation: no parts or recorder strips were returned to the teleflex (b)(4) facility for evaluation. Per the field service report, it was noted that the screen turned white and pump alarmed. The pump was checked by the distributor's engineering and the cpu board was found to be the problem and was replaced. The cpu was kept by the customer and is unavailable. A device history record (dhr) review was conducted for the iap and cpu board numbers and lot numbers with no relevant findings. The devices passed all manufacturing specifications prior to release. Conclusion: the reported complaint of "the screen turned white and the pump alarmed" is confirmed. The distributor's engineering checked the pump and replaced the cpu board. No parts or recorder strips are available to be returned to the teleflex (b)(4) facility for evaluation. The cause of the reported complaint could not be determined.
 
Event Description
It was reported per field service report: symptom - the screen turned white and the pump alarmed. The doctor changed the pump immediately as the pump stood idle. Findings / action taken: replaced the cpu (central processing unit) board. Software level: 2. 24.
 
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Brand NameAUTOCAT 2
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key5681861
MDR Text Key45997886
Report Number1219856-2016-00127
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0400
Device Lot Number0001021146
Other Device ID Number30801902051722
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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